Kratom is an opioid, has no medicinal purposes, FDA says

But kratom has gotten a free pass because of a President Clinton law that exempted supplements from FDA oversight as long as the label said that it was not a drug.

Still, concern about kratom is mounting, especially because some people appear to be using the supplement as a way to step down from opioid painkillers like heroin and morphine.

Forty-four deaths have been linked to the drug, according to the agency, and the majority of the cases involve the patient ingesting Kratom with another substance, like alcohol. Using a computer model, FDA researchers found that most of the compounds in kratom bind to opioid receptors in the body.

The FDA said Tuesday that claiming kratom is benign because its "just a plant" is "shortsighted and unsafe", as heroin comes from plants as well. Using this model, FDA scientists analyzed the chemical structures of the 25 most prevalent compounds in kratom and found that they all share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.

The FDA is warning individuals to avoid using kratom, which has been used by some as a remedy for opioid addiction and to treat addicts' medical conditions, as the herbal drug is "predicted to affect the body just like opioids" do. "Combined with psychosocial support, these treatments are effective". For example, calls to poison centers regarding kratom increased tenfold between 2010 and 2015, rising from 26 to 263, according to the U.S. Centers for Disease Control and Prevention.

The FDA has submitted its review to the DEA, which has not yet said whether it will escalate kratom's listing from "drug of concern" to a Schedule I substance. In November 2017, the FDA issued a public health advisory on the product to warn consumers about potential risks associated with its use. More than 63,000 Americans died in 2016 from drug overdoses, mostly from opioids.

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Their analysis also found that some of the kratom compounds may bind to the receptors in the brain that may contribute to stress responses that impact neurologic and cardiovascular function. The 3-D image generated showed that kratom has a strong bind to mu-opioid receptors, comparable to scheduled opioid drugs.

Low doses of kratom have stimulating properties while high doses can result in sedative and narcotic effects.

The statement released today detailed the reports on kratom-associated deaths.

"Cases of mixing kratom, other opioids and other types of medication is extremely troubling because the activity of kratom at opioid receptors indicates there may be similar risks of combining kratom with certain drugs, just as there are with FDA-approved opioids", Gottlieb said.

The FDA conducted a scientific analysis using a computational model developed by agency scientists, he said.

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